Ileostomies, colostomies, and similar procedures are surgically created openings in which a portion of the intestine is brought through the abdominal wall to form a stoma, which may be temporary or permanent depending on the reason for surgery, i.e., disease, injury, birth defects or cancer. A pouching system is used to collect waste material. There are two main types of systems commercially available: one-piece pouches with a built-in skin barrier, and two-piece systems composed of a skin barrier and detachable pouch. Skin barriers (or faceplates) are comprised of an adhesive layer formed of a soft skin-friendly hydrocolloid containing adhesive material and provide therein a centrally located aperture to receive a stoma. Systems may further provide a peel and stick tape on the outer edges of a faceplate for additional adhesion. Sticky skin wipes also help with adhesion of tape and the appliance faceplate. These faceplates are attached to the peristomal region of the user to protect the skin from irritating digestive juices. The two-part system provides a flange in the form of a pair of annular or ring-like rigid plastic parts designed to aid in either securing the pouch to the faceplate or removing the pouch at the user's discretion. Pouch styles and sizes vary from manufacturer to manufacturer and may or may not be equipped with a drainable end and may or may not have a filter. A convex faceplate is generally used when a stoma protrudes less than an inch and a flat faceplate is generally used when a stoma protrudes more than an inch.
Ostomates are faced with many problems associated with stomas and stoma waste collection pouches. One critical problem is loss of adhesion of the faceplate from an ostomate's skin, threatening a resulting loss of containment of waste. A faceplate cannot be checked for properly secured adhesion once it is applied to the skin. Loss of adhesion is common and unpredictable, even when directions for use are strictly followed. Subsequent leakage of waste can and does occur, often without warning, soiling clothes, causing unpleasant odors and embarrassment to the wearer. The wearer must immediately cease all activity and promptly address the situation, as flow of waste is continuous and involuntary. Although sticky skin preparations and adhesives are essential, they are not fail-proof due to uncontrollable factors influencing how long a pouching system will stay sealed. Among these factors are: changes in weight, perspiration, skin oils, watery discharge from foods, scars, and strenuous activities, such as sports or work. Fear of public humiliation due to such failures with the pouching adhesion causes many ostomates to avoid returning to normal lifestyle activities, including work and usual attire. There remains a need for a “second line of defense” or more aptly described—a fully engaged physical boundary for when these factors contribute to loss of adhesion.
Another dilemma faced by ostomates is ballooning of the pouch due to intestinal gas. This is especially true with filter-less pouches and presents difficulties over the six to eight hours the wearer is asleep.
Yet another problem faced by ostomates is the inability to return to wearing form-fitted jeans, trousers or other fitted clothing. In many cases, surgical placement of a stoma is often located near one's waistline and as a result, some part of a wearer's faceplate lies directly under a waistband. Current ostomy literature advises that one may return to one's normal mode of dress with a few exceptions. However, wearers often experience a feeling of irritation caused by constricted flow due to wearing form-fitted clothing, and this constriction contributes to loss of adhesion. There remains a need for a device to provide unrestricted flow of output while allowing current ostomy products to function as intended, and to provide a secure boundary against leakage while giving an ostomate the ability to wear form-fitted clothing.